MX2008008761A

MX2008008761A - One-way valve and apparatus and method of using the valve.

Info

Publication number: MX2008008761A
Application number: MX2008008761A
Authority: MX
Inventors: Daniel Py; Julian V Chan; Benoit Adamo; Nathaniel Houle
Original assignee: Medical Instill Tech Inc
Priority date: 2006-01-05
Filing date: 2007-01-05
Publication date: 2008-09-12
Also published as: BRPI0706436A2; WO2007133297A3; EP1973792A4; EP1973792A2; ZA200805870B; RU2008127114A; CN103964052B; CA2636311C; WO2007133297A2; CN101389542A; AU2007250178B2; CA2636311A1; CN103964052A; RU2527119C2; AU2007250178C1; AU2007250178A1

Abstract

A flexible pouch and valve assembly is provided for aseptically storing a substance, dispensing multiple portions of the stored substance therefrom, and maintaining substance remaining in the pouch in an aseptic condition sealed with respect to ambient atmosphere. The flexible pouch and valve assembly are receivable within a relatively rigid housing, and are adapted to cooperate with a pump for pumping discrete portions of substance from the pouch and through the one-way valve to dispense the substance therefrom. The assembly comprises a Flexible pouch defining therein a variable-volume storage chamber sealed with respect to the ambient atmosphere for aseptically storing therein multiple portions of the substance. A one way valve of the assembly includes a valve body defining an axially-extending valve seat and at least one flow aperture extending through the valve body and/or the valve seat. A valve cover is mounted on the valve body, and includes an axially-extending portion formed of an elastic material overlying the valve seat and covering a substantial axially-extending portion thereof. The valve portion defines a predetermined radial thickness and forms an interference fit with the valve seat. The valve portion and the valve seat define an axially-extending seam therebetween forming a normally closed, axially-extending valve opening, and the valve portion is movable radially between (i) a normally closed position with the valve portion engaging the valve seat, and (ii) an open position with at least a segment of the valve portion spaced radially away from the valve seat to connect the valve opening in fluid communication with the at least one flow aperture and thereby allow the passage of substance from the variable-volume storage chamber through the valve opening. In the normally closed and open positions, the one-way valve maintains substance remaining in the variable- volume storage chamber in an aseptic condition and sealed with respect to the ambient atmosphere.

Description

VALVE OF A DIRECTION AND APPARATUS AND METHOD FOR USING THE VALVE CROSS REFERENCE TO RELATED PATENT APPLICATIONS This patent application is a continuation in part of the patent application of E.U.A. Series No. 11 / 295,274, filed on December 5, 2005, entitled "Valve of a Direction and Apparatus Using the Valve", and claims priority to the provisional patent application of E.U.A. Series No. 60 / 757,161, filed on January 5, 2006, entitled "Valve of a Direction and Apparatus and Method to Use the Valve". Each of the above patent applications is hereby incorporated by reference in its entirety as part of the present disclosure.

FIELD OF THE INVENTION The present invention relates to one-way valves and apparatuses and methods using one-way valves, and more particularly, to one-way valves that define valve seats and flexible valve covers that overlap the valve seats, and suppliers and packaging that incorporate such valves and methods of use of such valves.

BACKGROUND INFORMATION Aseptic packaging is widely used to prolong the shelf life of food and beverage products. With conventional aseptic packaging, the product is filled and sealed in the package under sterile conditions or bacteria books. In order to maximize shelf life prior to opening, the product and the packaging material can be sterilized prior to filling, and the filling of the product in the packaging is carried out under conditions that prevent re-contamination of the product. A prior art dispenser system employing an aseptically filled package is shown in U.S. Patent No. 6,024,242. The package includes a bag that supports the food or drink, and a flexible tube, open end connected to the bag to distribute the product through it. A control valve is used in the distributor to control the open end of the tube and thereby close the tube of the ambient atmosphere. In order to distribute the product, the control valve is released from the tube, and the product in turn is allowed to flow out of the bag and through the open end of the tube. One of the disadvantages of this type of prior art and packaging distributor is that during the installation of the bag and tube assembly in the distributor, and during distribution, there is a risk that bacteria or other unwanted substances may enter the Open end tube and contaminate the product. If the product is a non-acidic product such as a milk-based product, it must be kept under refrigeration to ensure the life of the product. It is an object of the present invention to overcome one or more of the disadvantages and / or drawbacks described above in the prior art.

BRIEF DESCRIPTION OF THE INVENTION According to a first aspect, the present invention is directed to a flexible bag and valve assembly for aseptically storing a substance, distributing multiple portions of the stored substance thereof, and maintaining substance remaining in the bag in an aseptic condition sealed with regarding the environmental atmosphere. The flexible bag and a valve assembly can be received within a relatively rigid housing, and are adapted to cooperate with a pump to pump separate portions of substance from the bag and through the valve of one direction to distribute the substance thereof. . The assembly comprises a flexible bag defining therein a storage chamber of variable volume sealed with respect to the ambient atmosphere for aseptically storing multiple portions of the substance therein. A valve of one direction of the assembly includes a valve body defining an axially extending valve seat, and at least one flow opening extending through at least one of the valve body and valve seat. A valve cover is mounted on the valve body, and includes an axially extending portion formed of an elastic material that covers the valve seat and covers a substantially axially extending portion thereof. The valve portion defines a predetermined radial thickness and forms an interference fit with the valve seat, the valve portion and the valve seat define an axially extended joint therebetween which forms a normally closed, axially extending valve opening. , and the valve portion is movable radially between (i) a normally closed position with the valve portion that engages the valve seat, and (ii) an open position with at least one segment of the valve portion spaced radially. away from the valve seat for connecting the valve opening in fluid communication with at least one flow opening and thereby allowing the substance passage of the variable volume storage chamber through the valve opening. In normally closed and open positions, the one-way valve maintains the substance that remains in the storage chamber of variable volume in an aseptic condition and sealed with respect to the ambient atmosphere. In some embodiments of the present invention, the flexible bag defines a sealed, empty, aseptic storage chamber adapted to receive therein a substance for storage and distribution thereof. In some embodiments of the present invention, the flexible bag is aseptically filled with a substance that is at least one of a food and beverage. In such an embodiment, the bag is formed of a plastic laminate that includes an oxygen / water barrier and an approved food contact layer. In such modality, the substance is selected from the group that includes a product based on milk, milk, evaporated milk, condensed milk, cream, half and half, formula for baby, growth milk, yogurt, soup, ice cream, juice, syrup , coffee, condiments, ketchup, mustard, mayonnaise, and coffee aroma. Some embodiments of the present invention further comprise a flexible tube coupled in fluid communication between the bag and valve of a direction. In such an embodiment, the flexible tube is connected to the flexible bag and one-way valve by at least one of (i) a fitting mounted to at least one flexible bag and a one-way valve that is fi rmly coupled to a respective end. of the tube to form an airtight seal between them, (i) a heat seal, (iii) a weld, and (iv) an adhesive. In some embodiments of the present invention, the assembly further includes an elastic actuator coupled in fluid communication between the bag and valve of a direction that is manually movable to pump the substance of the storage chamber of variable volume through the valve. one direction. In such an embodiment, the elastic actuator is approximately dome-shaped. Some such embodiments also comprise a manually operated operator that is manually engageable to press the elastic actuator and, in turn, distribute the substance from the variable volume storage chamber through the one-way valve. In some such embodiments, the manually engageable operator is a lever. In some embodiments of the present invention, the assembly further comprises a relatively rigid container that receives therein the flexible bag. In some such embodiments, the relatively rigid container is made of cardboard or plastic. According to another aspect, the present invention is directed to the assembly in combination with a distributor. The dispenser comprises a relatively rigid container that receives in it the flexible bag, and a surface for supporting and placing the valve of an address for distributing substances thereof and inside the container. In such modality, the distributor also includes a relatively coupled pump between the storage chamber of variable volume and the valve of an address, and a control unit electrically coupled to the pump to control operation of the pump and, in turn, control the distribution of substance within the storage chamber of variable volume, through the one-way valve, and in the another container. In one embodiment, the dispenser includes at least one bag, and at least one bag includes at least one of coffee, concentrated coffee, milk, milk-based product, half-and-half, and sand. In one embodiment, the dispenser further includes at least one bag containing coffee flavor.

According to another aspect, the present invention is directed to a flexible bag and valve assembly for aseptically storing a substance, distributing multiple portions of the substance stored therein, and maintaining substance remaining in the bag in a sealed aseptic condition with respect to to the environmental atmosphere. The flexible bag and the valve assembly can be received within a relatively rigid housing and adapted to cooperate with a pump for pumping separate portions of substances from the bag and through the one-way valve to distribute the substance therefrom. . The assembly comprises first means defining therein a flexible bag, storage chamber of variable volume sealed with respect to the ambient atmosphere for aseptically storing multiple portions of the substance therein. The assembly further comprises second means for allowing the variable volume storage chamber substance to be distributed through it, and for keeping the substance remaining in the variable volume storage chamber in an aseptic and sealed condition with respect to the environmental atmosphere during and after distribution of substance through it. The second means includes third means for forming an axially extending valve seat and at least one flow opening. The second means also include fourth means mounted on the third means and defining an elastic, axially extending portion covering the third means and covering a substantially axially extending portion thereof, defining a predetermined radial thickness that forms an interference fit with the third means, and defining a joint extending axially between the third and fourth means, to form a normally closed, axially extending valve opening, and to move radially between (i) a position normally closed with the fourth means engaging with the third means, and (ii) an open position with at least one segment of the fourth means spaced radially away from the third means, to connect the valve opening in fluid communication with at least one an opening of flow and thereby allow the passage of substance from the storage chamber of variable volume through is from the valve opening. The fourths cooperate with the third means to maintain the substance that remains in the storage chamber of variable volume in an aseptic condition and sealed with respect to the ambient atmosphere in the normally closed and open positions. In one embodiment of the present invention, the variable volume storage chamber comprises a milk-based product, and the second means is to prevent microorganisms from entering the storage chamber of variable volume and to allow the product based on Milk is stored and distributed without refrigeration. In one embodiment of the present invention, the first means is a flexible bag, the second means is a one-way valve, the third means of a valve body, and the fourth means is a flexible valve cover. According to another aspect, the present invention is directed to a method for storing fluid and distributing multiple portions of stored fluid thereof, comprising the following steps: (1) providing a storage chamber and storing multiple portions of the fluid therein; an aseptic condition; (2) providing a one-way valve assembly that includes (i) a valve body defining a valve seat and a flow opening that extends through at least one of the valve body and valve seat; and (ii) a valve cover formed of an elastic material and including a valve portion that covers the valve seat, wherein the valve portion defines a predetermined radial thickness and forms an interference fit with the valve seat., the valve portion and the valve seat define a normally closed valve opening, which extends axially therebetween, and the valve portion is movable relative to the valve seat between a normally closed position with the valve portion that is the valve seat engages, and an open position with at least one segment of the valve portion spaced away from the valve seat to connect the valve opening in fluid communication with the flow opening and thereby allow the passage of fluid from the valve seat. the flow opening through the valve opening; and (3) maintaining the fluid in the storage chamber in an aseptic condition during shelf life and distributing the fluid through the one-way valve assembly. In some embodiments of the present invention, the method further comprises the step of providing a sealed hermetically variable volume storage chamber and storing multiple portions of the fluid therein in a substantially airless condition, and maintaining the fluid in the storage chamber of the container. variable volume substantially airless during shelf life and distribution of fluid through the one-way valve assembly. In some embodiments of the present invention, the method further comprises the step of providing a pump coupled between the storage chamber and the one-way valve assembly and pumping separate portions of fluid from the storage chamber with the pump through the pump. the flow opening, and in turn through the valve opening. In some embodiments of the present invention, the method further comprises the steps of: (i) providing at least one storage chamber, pump, and one-way valve assembly with a penetrable needle and thermally annotated portion; and (ii) filling the storage chamber with the fluid upon penetration of the penetrable needle and thermally resealable portion with a needle, introducing the fluid through the needle and into the storage chamber, withdrawing the needle, and hermetically resealing a needle orifice. The resulting needle in the penetrable needle and thermally resealable portion when applying thermal energy to it. In such embodiment, the method further comprises the step of forming a penetrable substantially transparent needle and thermally resealable portion by combining (i) a styrene block copolymer; (ii) an olefin; (iii) a pigment added in an amount less than about 150 ppm; and (iv) a lubricant. In such an embodiment, the pigment is a substantially transparent infrared absorber. In some embodiments of the present invention, the variable volume storage chamber is defined by (i) a flexible bag, which includes, for example, the inside of a flexible bag, or the space between a flexible bag and a relatively rigid cup or a similar body, or (ii) a rigid body including, for example, a piston slidably received within the body, and forming a fluid-tight seal between a peripheral portion of the piston and the body, and defining the storage chamber of variable volume between the piston and the flow opening of the one-way valve assembly. In an alternative embodiment, a vessel or other body defines the storage chamber therein and includes a filter coupled in fluid communication between the storage chamber and the ambient atmosphere to filter air or other gas flowing into the chamber when distributing fluid from This is to sterilize the air or other gas flowing in the chamber and thereby maintain an aseptic condition of the fluid within the chamber. In each case, the method further comprises the step of sterilizing the sealed, empty flexible variable storage chamber or other pre-storage chamber to the same filler. Preferably, the sterilization step includes at least one of (i) transmission radiation, such as beam gamma radiation E, and (ii) transmitting a fluid sterilant, such as VHP, into the storage chamber.

In some embodiments of the present invention, the method comprises the step of aseptically filling the storage chamber with at least one milk-based product, a baby formula, and a water-based product. One such embodiment further comprises the step of keeping the milk-based product, infant formula, or water-based product substantially free of preservatives substantially through the filling and distribution of the product. A further embodiment comprises the step of maintaining the milk-based product, infant formula, or water-based product of substantially at room temperature through the shelf life and distribution of multiple product services from the storage chamber. Some embodiments of the present invention further comprise the steps of: (i) providing a flexible tube coupled at one end in fluid communication with the storage chamber, and coupled at the other end in fluid communication with a one-way valve assembly , and a pump in the form of a peristaltic pump; and (ii) coupling with the peristaltic pump an outer portion of the flexible tube and pumping separated portions of fluid therethrough. Other embodiments of the present invention further comprise the steps of: (i) providing a pump in the form of a manually engageable pump or foot operated pump that includes a compression chamber, a comprehensive surface that is received within the compression chamber , and an operable manually operable actuator coupled to at least one compression chamber and comprehensive surface; and (ii) manually engaging the manually engageable actuator or engaging the pedal and moving the actuator to operate at least one of the compression surface and compression chamber relative to the other between a rest position and at least one actuated position and, at its Once, pressurize fluid into the compression chamber and distribute fluid through the one-way valve assembly. An advantage of the apparatus and method of the present invention is that the one-way valve assembly can hermetically seal the product in the variable volume storage chamber through shelf life and multiple product distribution. As a result, non-acid products, such as milk-based products, do not require refrigeration during shelf life or product use. Other advantages of the apparatus and method of the present invention will be readily apparent in view of the following detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a side elevational view of an apparatus depicting the present invention that includes a one-way valve and tube assembly; Figure 2 is a view in some schematic form of a dispenser employing the valve of a direction and tube assembly in combination with a reservoir storing a substance to be dispensed, and a pump for pumping the substance from the reservoir through the tube and one-way valve assembly; Figure 3 is a cross-sectional view of the one-way valve assembly of Figure 1; Figure 4 is a front perspective view of the one-way valve assembly of Figure 1; Figure 5 is a front perspective view of another embodiment of a one-way valve assembly with the flexible valve cover removed, and including a beveled edge on the dispensing joint to prevent pickup of substance at the tip after distribution; Figure 6 is a partial cross-sectional view of the valve body and adjusting the valve assembly of a direction of Figure 5; Figure 7 is a view in some schematic, partial cross-sectional form of a flexible bag, tube and valve assembly received within a box and mounted within a distributor; Figure 8 is a perspective view of the flexible bag, tube and valve assembly of Figure 7; Figure 9 is an exploded cross-sectional view of a port located in the flexible bag of Figure 7 which includes a penetrable needle and re-attachable laser needle plug that penetrates the cap and fills the bag with a fluid through it. and laser resealing of the resulting needle hole in the cap after removal of the needle therefrom; Figure 10 is a perspective view of another embodiment of a valve assembly of the present invention that includes a manually-actuated, dome-shaped actuator for pumping fluids through the valve, wherein the valve is mounted in a box and it is coupled in fluid communication with a flexible bag located inside the box; Figure 11 is a cross-sectional view of the valve assembly of Figure 10; Figure 12 is a rear perspective view of the valve assembly of Figure 11; Figure 13 is a top perspective, cross-sectional view of the valve assembly of Figure 11; Figure 14 is an elevation view of the valve assembly of Figure 11 attached to the flexible bag; Figure 15 is a cross-sectional perspective view of the valve assembly of Figure 11 attached to a rigid body including a plunger slidably received therein and formed with the body of a variable valve storage chamber; Figure 16 is a cross-sectional view of another embodiment of a valve assembly, dome-shaped actuator, and flexible bag coupled in fluid communication with the dome-shaped actuator and valve assembly and mounted within a relatively container rigid; Figure 17 is a top plan view of the adjustment ring of the assembly of Figure 17 securing the integral dome-shaped actuator and valve cover to the container; and Figure 18 is a top plan view of the integral dome-shaped actuator and valve cover of Figure 16. Figure 19 is a schematic, cross-sectional view of another apparatus of the invention including a bladder. expandable or bag mounted within a relatively rigid container and defining a storage chamber of variable volume between them, and a pump and valve assembly of an address coupled in fluid communication with the variable volume storage chamber to distribute the product of fluid from this. Figure 20 is a view in some schematic, cross-sectional form of another apparatus of the invention that includes a container defining a storage chamber therein, a microbial coupled in fluid communication between the ambient atmosphere and the storage chamber for filtering and, in turn, sterilizing the air flowing in the chamber, and a pump and valve assembly of an address coupled in fluid communication with the storage chamber to distribute the fluid product thereof. Figure 21 is a view in some schematic, cross-sectional form of another apparatus of the invention that includes a flexible bag defining therein a storage chamber of variable volume and mounted within a relatively rigid condenator, a source of pressurized air or another gas coupled in fluid communication with the chamber formed between the flexible bag and container to pressurize the fluid product in the bag, and a release valve and valve assembly of a direction coupled in fluid communication with the storage chamber of volume of variable to release the pressurization fluid in the storage chamber through the one-way valve assembly. Figure 22 is a view in some schematic, cross-sectional form of another apparatus of the invention that includes a peristaltic pump operated manually or by pedal to pump fluid product from the storage chamber of variable volume through the valve of a address. Figure 23 is a view in some schematic, cross-sectional form of another apparatus of the invention that includes a manually operated oscillator arm pump for pumping fluid product from the variable volume storage chamber through the one-way valve .

DETAILED DESCRIPTION OF THE INVENTION In Figures 1 and 2, the apparatus embodying the present invention is generally indicated by the reference number 10. The apparatus 10 comprises a one-way valve assembly 12 connected in fluid communication with a tube 14. The apparatus 10 is used to seal a substance within the tube 14 sealingly with respect to the ambient atmosphere and to distribute the substance through the one-way valve assembly 12. The substance may take the form of any of the numerous different products currently known, or which will subsequently be known, including without limitation any of the numerous different food and beverage products, such as milk-based products, including milk, evaporated milk, condensed milk, cream, half and half, baby formula, milk of growth, yogurt, soup, low acid fluid, acid-free fluids, and any of numerous other liquid nutrition products, hel ado (which includes dairy and non-dairy products, such as soy-based ice cream), juice, syrup, coffee, condiments, such as ketchup, mustard, and mayonnaise, gases, such as coffee aroma, and biological or biopharmaceutical products, such as vaccines, monoclonal antibodies and genetic therapies. With reference to Figure 2, the apparatus 10 can be mounted within a manifold 16 comprising the pump 18 which is connectable to the tube 14 to compress the tube and, in turn, distribute a substance within the tube through the valve of an address 12 and in a container 20. The dispenser also includes a reservoir 22 which in the illustrated embodiment defines a storage chamber of variable volume 24 for storing the substance to be dispensed. The reservoir 24 includes a fitting 26 connected to the end of the tube 24 opposite the one way valve 12 and coupled in fluid communication between the tube and the variable volume storage chamber 24 to allow the passage of substance from the storage chamber to the tube. Alternatively, the tube can be heat sealed, welded, adhesively bonded, or otherwise connected to the reservoir, or material forming the reservoir, such as a plastic or laminated bag, in any of a number of presently known ways, or They will be known later. The distributor 16 also includes a housing 28 for enclosing the components as illustrated, and includes access panels or other openings in a manner known to those skilled in the art to allow access to the interior of the housing to install a fresh deposit when empty the tank, and to repair or replace components. As shown in Figure 3, the one-way valve assembly includes a valve body 30 defining a first axially extending passage 32, an axially extending valve seat 34, and a flow opening 36 that it extends axially through the valve body 30 adjacent the valve seat 34 and coupled in fluid communication with the first axially extending passage 32. The one-way valve assembly 12 further includes a valve bowl 38 formed of a elastic material and including a cover base 40 mounted on the valve body 30 and fixedly secured against axial movement relative thereto, and a valve portion 42 covering the valve seat. The valve portion 42 defines a predetermined radial thickness and an inner diameter D1 smaller than the outer diameter D2 of the valve seat 34 to thereby form an interference fit therebetween, as indicated by the overlap lines in Figure 3. As can be seen, valve portion 42 and valve seat 34 define a normally closed, axially extending valve opening or union 44 therebetween. As further described below, the valve portion 42 is movable radially between a normally closed position, as shown in Figure 3, with the valve portion 42 that engages the valve seat 34, and an open position (not shown) with at least one segment of the valve portion 42 spaced radially away from the valve seat 34 to connect the valve opening 44 in fluid communication with the flow opening 36 to thereby allow the passage of substance into the flow opening 36 through the valve opening 44. Also as shown in Figure 3, an adjustment 46 is fixedly secured to the valve body 30 and forms an airtight seal therebetween. The adjustment 46 defines a second passage 48 coupled in fluid communication with the first axially extending passage 32 to allow the flow of 2! substance between them, and an axially extending annular tube connecting surface 50 which is hermetically connectable to the tube 14 with the second passage 48 engaged in fluid communication with the tube to thereby allow the passage of substance from the tube 14, through the second passage 48 and, in turn, through the first axially extending passage 32, flow opening 36 and valve opening 44. As shown in Figure 3, the valve body 30 further includes a base body 52 including an annular mounting edge 54 extending radially outwardly thereof for mounting the valve assembly in, for example, the distributor 16 of Figure 2. The valve body 30 also defines a first frustrous portion. substantially conical 56 extending between the body base 52 and the valve seat 34. As can be seen, the flow opening 36 extends axially through the first substantially frustro-conical portion 56 so that the radially internal edge of the flow opening 36 is substantially contiguous with the valve seat 34. The valve cover 38 includes a second portion substantially frustro-conical 58 extending between the cover base 40. and the valve portion 42, which covers the first substantially frustro-conical-shaped portion 56 of the valve body 30, and, as indicated by the overlap lines in Figure 3, which form an interference fit therebetween. As can be seen in Figure 3, the substantially fustrous-conical portions if valve 58 and 42, respectively, of the valve cover 38 can define a progressively decaying radial thickness when moving axially in a direction from the frustrous portion. substantially conical 58 towards the valve portion 42. As a result, progressively less energy is required to open the valve when it moves axially in the direction from the inside to the outside of the valve. The substance is distributed through the valve by pumping the substance to a sufficient pressure (either by manually, mechanically or electromechanically pressing tube 14, or otherwise pumping the substance through the tube or into the valve) through the flow opening 36 for opening the valve opening or junction 44 (the "valve opening pressure"). Once the pressurized substance enters the valve opening or junction 44, progressively less energy is required to radially open respective axial segments of the valve cover when moving axially in the direction from the inside to the outside of the valve. As a result, the valve itself operates as a pump to force the substance through the normally closed valve opening 44. Preferably, a substantially annular segment of the valve portion 42 engages the valve seat 34 substantially through the valve. any period of distribution substance through the valve opening 44 to maintain a hermetic seal between the valve opening 44 and the ambient atmosphere. If desired, the valve can be configured in other ways in order to require progressively less energy to open the valve (i.e. to decrease the valve opening pressure) when moving in the axial direction from the inside to the outside of the valve. The valve. For example, valve cover 38 and valve body 30 can define a lesser degree of interference between when moving in the direction from the inside to the outside of the valve assembly. Alternatively, the valve seat 34 may define a progressively increasing diameter when it moves axially in the direction from an inner end towards a distal end of the valve seat (or from the inner end towards the outer end of the valve seat). If desired, the valve assembly may include only one of these aspects, or may include any combination of these aspects in order to achieve the desired performance characteristics. The valve assembly 12 of another form is preferably constructed in accordance with the teachings of the following commonly assigned applications, of co-pending patents that are incorporated herein by reference in their totalities as part of the present description: Patent application of E.U.A. Series No. 10 / 640,500, filed August 13, 2003, entitled "Container and Valve Assembly for Storing and Distributing Substances, and Related Method", U.S. Patent Application. Series No. 29 / 174,939, filed January 27, 2003, entitled "Container and Valve Assembly", Patent Application of E.U.A. 60 / 613,583, filed September 27, 2004, entitled "Laterally Actuated Distributor with Valve of an Address for Storing and Distributing Quantities of Measured Substances", U.S. Patent Application. Series 29 / 188,310, filed August 15, 2003, entitled "Tube and Valve Assembly", US Patent Application Series No. 29 / 191,510, filed October 7, 2003, entitled "Container and Valve Assemblies", and US Patent Application Series No. 60 / 528,429, filed December 10, 2003, entitled "Valve Assembly and Tube Equipment for Storing and Distributing Substances, and Related Methods". According to such teachings, at least one of the valve seat diameter D2, the degree of interference between the valve portion 42 and valve seat 34 (as indicated by the overlap lines in Figure 3), the radial thickness The predetermined valve portion 42, and a predetermined modulus of elasticity of the valve cover material 38, is selected to (1) define a predetermined valve opening pressure generated by pressing the tube 14 allowing the passage of the substance from the tube through the normally open valve opening 44, and (2) hermetically sealing the valve 12 and preventing the ingress of bacteria or contamination through the valve opening 44 and the tube 14 in the normally closed position. In the illustrated embodiment of the present invention, each of the valve seat diameter D2, the degree of interference between the valve portion 42 and the valve seat 34, the predetermined radial thickness of the valve portion 42, and the module The elasticity preset of the valve cover material 38 is selected to (i) define a predetermined valve opening pressure generated by tightening the tube 14 allowing the passage of the substance from the tube (or storage chamber of variable volume coupled in fluid communication thereto) through the valve opening 44, and (i) hermetically sealing the valve opening 44 and preventing the ingress of bacteria through the valve opening and into the tube in the normally closed position . The flow opening 36 extends angularly relative to the valve seat. In the illustrated embodiment, the flow opening regularly extends within the range of about 30 degrees to about 45 degrees. However, as can be recognized by those skilled in the pertinent art based on the teachings herein, this angular scale is only illustrative, and may be changed as desired, or otherwise required. In addition, one or more additional flow openings 36 may be added and spaced angularly relative to opening 36 as shown, for example, in any of the commonly assigned, co-pending patent applications incorporated by reference above. As shown in Figure 3, the valve body 30 defines an annular recess 60 formed in the junction of the base 52 and the frusto-conical portion 56. The valve cover 38 includes a corresponding annular rim 62 which projects radially. inwardly, it is received within the annular recess 60 of the valve body 30 to secure the valve cover to the valve body. As can be seen, the valve body 30 defines a narrowed surface 64 on the outside axially or the front side of the annular recess 62 to facilitate movement of the annular rim 62 in the annular recess 60.

The valve assembly 12 further includes a protective cover or shield 66 that extends annularly over the flexible valve cover 38, and extends axially from the base of the valve cover 38 to a point adjacent to the valve distribution tip. but it is spaced axially inward of it. As shown in Figure 3, the valve body 30 defines a first peripheral recess 68 formed in the joint at the mounting edge 54 and the body base 52, and the valve shield 66 defines a corresponding first annular protrusion 70 which it projects radially inwardly and fits in the peripheral recess 68 to close the valve shield to the valve body. In addition, the valve shield 66 defines a second peripheral recess 72 formed in the axially inner side of the first annular protrusion 70, and the body base 52 defines a second corresponding annular protrusion 74 which projects radially outward and fits in the peripheral gap 72 to further close the valve shield to the valve body. As also shown in Figure 3, the valve shield 66 is spaced radially relative to the second frusto-conical portion 58 and the valve portion 42 of the valve cover 38 to form an annular, axially extending space 76 among them. The space 76 allows the valve cover to expand freely or move radially outward during substance distribution through the normally closed valve opening or junction 44. The tip 78 of the valve portion 42 defines an annular portion 80. which tapers radially outward towards the distal end 82 of the valve shield 66 to substantially block, or block a substantial portion of, the distal end of the annular space 76 thereby preventing any of the unwanted substances from being re-deposited here. The fit 46 includes an annular mounting edge 84 which is received within a corresponding mounting recess 86 for mounting the valve body 30 fit. As shown in Figure 3, the fit and the valve body form an interference in the inner annular surfaces 88 and 90 thereof to permit adjustment and the valve body to ultrasonically weld together and form an airtight seal between them in the annular coupling line of these surfaces. An advantage of the illustrated engagement joint design is that it ensures relatively high joint strength and an airtight seal therethrough. As can be recognized by those skilled in the art based on the teachings herein, the fit and valve body can be connected to each other in any of a number of different ways that are currently known, or will be known later. Alternatively, the fit and the valve body can be formed integral with each other when the valve body is molded and adjusted. An advantage of forming the separate adjustment of the valve body is that different sizes or adjustments, and / or different types of adjustments, can be attached to the valve bodies. As shown in Figure 3, the tube connection surface 50 is a conventional barbed fitting surface that frictionally engages the interior of the flexible tube 14 to secure the fit to the tube and form a tight seal therebetween. In the illustrated embodiment, the tube 14 is a conventional silicone tube. However, as can be recognized by those skilled in the pertinent art based on the teachings herein, the fit and / or tube may take the form of any of numerous different configurations and / or may be formed from any of a number of different materials currently being know, or will be known later. As shown in Figure 2, the valve and tube assembly 10 can be mounted within a manifold 16 and connected to a conventional peristaltic pump 18 which is rotatably driven, as indicated by the arrows in Figure 2, to press the tube 14 and, in turn, pump the substance from the reservoir 24, through the one way valve 12, and into a receiving container or other receptacle 20. Alternatively, the valve and the tube assembly 10 can be mounted within any of a number of different pumps, such as electrically operated, manually operated, or pedal operated pumps, or can be used with jets employing pressurized air or other gas for pumping. the fluid through the valve, which are currently known, or will be known later. In Figures 5 and 6, another valve assembly representing the present invention is generally indicated by the reference number 112. The valve assembly 112 is substantially similar to the valve assembly 12 described above, and therefore similar reference numbers Preferred by the number "1" are used to indicate similar elements. The primary difference of the valve assembly 112 as compared to the valve assembly 12 is that the valve seat distribution tip 134 defines hollow 192 therein, and a very thin, annular beveled edge 194 formed between the hollow 192 and the distal edge of the valve seat 134. As can be seen, the radial width of the beveled edge 194 is substantially less than the axial depth of the recess 192 and the diameter of the valve seat 134 (by a magnitude in both cases of at least about 5). and preferably at least about 10). In one embodiment of the present invention, the radial width of the end portion is within the range of about 5 mm to about 25 mm. An advantage of this configuration is that the thin, annular edge 194 substantially prevents any substance from being collected at the dispensing tip after being dispensed from the valve. Preferably, the valve 112 is mounted in a substantially vertical or straight orientation (as typically shown in Figure 2) so that the dispensing tip is oriented downward (either so that the valve axis is oriented substantially parallel to, or at an acute angle relative to, the horizontal). The light surface area of the annular angle 194 substantially prevents any fluid flowing on the surface from having sufficient surface tension to overcome the gravity force of gravity which pulls the fluid down and away from that surface. As a result, the annular rim 194 substantially prevents any fluid or other substance from being collected therein, and thereby facilitates the maintenance of a clean dispensing tip. In Figures 7-9, another tube and valve assembly representing the present invention are generally indicated by the reference numeral 210. The tube and valve assembly 210 are substantially similar to the tube and valve assemblies 10, 110 described above. , and therefore reference numbers preceded by the number "2", or preceded by the number "2" instead of the number "1", are used to indicate similar elements. A primary difference of the tube and the valve assembly 210 as compared to the tube of the valve assemblies described above, is that the tube 214 is formed integral with a flexible bag forming the reservoir 224, and the flexible bag, tube and assembly Valves can be mounted within a relatively rigid case 225. In one embodiment, the inlet end 226 of the tube 214 is constructed in the base of the bag 222, such as by heat sealing, ultrasonic welding, grasping, or adhesive bonding. tube to the bag material. As one skilled in the pertinent art can recognize based on the teachings herein, the tube can be connected in fluid communication with the bag, or formed integral with the bag, in any of many different ways currently known, or will be known later. As indicated in Figure 7, when mounted within the distributor housing 216, the tube 214 is coupled to a peristaltic pump 218 of a type known to those skilled in the pertinent art, and the valve assembly 212 extends through a distribution aperture 221 formed in a panel 223 of the distributor housing 216. As can be seen, the mounting edge 254 sits on the inner side of the panel 223, and a clamp 229 with one or more suitable fasteners 221, such as thumb screws, which secure releasably valve 212 in place. A control unit 233 is electrically coupled to the pump 218 to control the operation of the pump and, in turn, control the distribution of the food or drink product or other substance within the reservoir 224 of the bag 222 through the tube 214 , one-way valve assembly 212, and in the cup or other receptacle 220. The dispenser may include suitable controls that allow a user to operate on the control unit 233 and the pump 218, such as buttons or switches, all of a type known to those skilled in the relevant art. In one embodiment, the bag 222 is an oxygen / water barrier material. An example of such material is a plastic laminate with a layer of proven food contact material. In such an embodiment, the material is a heat sealable film that includes an oxygen / water barrier layer and, preferably, an outer layer exhibiting appropriate wear and flexibility properties. Examples of suitable outer layers are nylon, either linear or biaxially oriented, polyethylene, polypropylene, and polystyrene. Examples of oxygen / water barrier materials are ethylene vinyl alcohol (EVOH) and silicon oxide. An illustrative heat sealable material is polyethylene, such as linear low density, linear low density, high density or metallocene catalyzed polyethylene. An illustrative bag material is a laminate including a nylon copolymer, on the outside, EVOH, metallocene catalyzed polyethylene in the interior, wherein the laminate layers adhere together in a manner known to those skilled in the relevant art. As can be recognized by those skilled in the relevant art, if the tube is not provided as an integral part of the bag, anti-block additives should be avoided to ensure good bag edge / tube function. The tube 214 is preferably made of a material that is sufficiently soft so that it can be compressed or otherwise deformed, for example, by the peristaltic bag 218, but not puncture or permanent deformation when compressed or deformed. In one embodiment of the present invention, the material is a co-extruded metallocene-catalyzed polyethylene, such as the metallocene-catalyzed resin sold by Dow Chemical Corporation under the designation Dow AG 8180. As indicated above, the tube material may be sealed by heat, taken, or adhesively attached to the bag material. The dimensions of the tube 214 can be adapted to the type of food material or other substance to be distributed through this. In some embodiments, the inner diameter of the tube is within the range of about 5 mm to about 15 mm, and is preferably within the range of about 7 mm to about 8 mm. In some such embodiments, the thickness of the tube material is within the range of about 1 mm to about 2 mm, and in one embodiment, the thickness is about 1.5 mm. The length of the tube 214 can be set as desired or otherwise required by a particular distribution system. In some embodiments, the length of the tube is within the range of about 15 cm to about 25 cm. As can be recognized by those skilled in the relevant art based on the teachings here, the materials of construction of the bag, tube and valve assembly, can take the form of any of numerous different materials that are currently known, or that will be known later to perform the functions of the respective components. Similarly, the dimensions of these components, and the manner in which these components are connected or otherwise formed, can take any of numerous different dimensions or configurations as desired or as otherwise required. For example, the materials of the bag, or the dimensions of the bag and tube, may be the same as described in the U.S. Patent. No. 6,024,252, which is hereby expressly incorporated by reference in its entirety as part of the present disclosure. Depending on the design of the housing 216 of the dispenser, it may not be necessary to order the bag 222 within the box 225. However, the box 225 may provide a convenient mechanism for holding and transporting the flexible bag 222, and / or for mounting the bag 222 within the distributor housing 216. In one embodiment of the present invention, the box 216 is a cardboard box of a type known to those skilled in the relevant art. As shown in Figure 9, the box 225 can define an opening 227 that extends through a base wall thereof that allows the tube and valve assembly to pass therethrough. Alternatively, the box 225 may be provided with a perforated or brittle portion that allows the part of the box to be removed to access the tube and valve assembly. As can be recognized by those skilled in the pertinent art based on the teachings herein, the box may be formed of any of a number of different materials, and may define any of numerous different forms and / or configurations, which are currently known, or which will be known subsequently. . In addition, the flexible bag and the valve assembly can be mounted within any of the numerous different containers or dispensers, and can be used in combination with any of the numerous different pumps, such as electrically driven, manually operated, or pedal operated pumps, or they may be used by jets employing pressurized air or other gas to pump or otherwise pressurize the fluid to the flow through the valve, which are currently known, or which will be known later. As shown in Figures 7-9, bag 222 preferably includes a penetrable needle and resealable plug 235 only for filling reservoir 224 through the plug with a needle or other injection member, and thermally resealing the resulting needle orifice with laser or other thermal or chemical source. As can be seen, plug 235 is mounted or otherwise received within a port 237 that extends through an upper portion of bag 222. As shown in Figure 9, port 237 may extend through an opening formed in an upper wall of the box 225. If desired, a support ring 239 can be located between an edge 241 of the port 237 and the adjacent wall of the box 225. As can be seen, the support ring 239 is extends laterally (or radially outwards) of the port to support the port during needle filling and resealing through the cap. The bag, tube and valve assembly are preferably sterilized prior to filling, for example, by applying radiation, such as gamma or E beam radiation thereto, or another type of sterilant, such as vaporized hydrogen peroxide ("VHP"). . Then, the hermetically sealed, sterilized, empty bag, tube and valve assemblies are filled aseptically with liquid food, drink or other substance to be contained therein. An advantage of this filling method is and construction is that it provides improved shelf life of the substance inside the bag, and allows the bag to not be refrigerated during storage and through the use of the bag (i.e., the bag may remain uncooled from the first to the last dose distributed from the bag). If desired, and as typically indicated in the lines divided in Figure 7, a counterfeit-proof cover 243 can be secured to the projection 241 of the port after needle filling, and thermally resealing the cap 235 in order to prevent removal of the plug, or otherwise tampering with the plug, without damaging the cover 243. The plug 235 forms a peripheral seal hermetically sealing the fluid with the port 237 in a manner known to those skilled in the pertinent art. In addition, the cover 243 can form a fluid tight seal between the stopper and the ambient atmosphere and, in turn, provide additional moisture and / or vapor transmission barrier between the stopper and the ambient atmosphere. The cover 243 may be connected to the port in any of a number of different ways that are currently known, or will be known later, including by adjusting connection, ultrasonic welding, adhesive, or otherwise. As shown in Figure 9, in an alternative configuration, plug 235 can be retained within port 237 by a cover 245 that fits port 237 to securely lock the plug within the port. The cover 245 includes an inner edge 247 that engages a peripheral edge 249 of the cap 235 to securely plug the port. The inner edge 247 defines a central opening 251 for receiving therein a central raised portion 253 of the cap 235 defining the penetrable needle and the thermally resealable portion of the cap. The cover 245 further defines a plurality of adjusting edges 255 spaced apart relative to one another under the inner edge 247. Each adjustment edge 255 defines a constricted cross-sectional configuration to allow the cover 245 to be slidably mounted over the edge 237 port 239 and to form a fit in the coupling with the underside of port edge 237 to prevent the cover from being removed from the port. Preferably, as when adjusted in place, the inner edge 247 applies a substantially predetermined comprehensive preload for the elastic edge 249 of the plug 235 to thereby form a fluid-tight seal between the cover, plug and port. In addition, the inner peripheral edge 257 of the plug is configured in a manner known to those skilled in the pertinent art based on the teachings herein to couple the internal surfaces of port 237 and form a fluid tight seal between them through life in a moment. and use of the bag. The cover 245 includes a cover disc 259 which is received within a peripheral recess 261 formed within the cover on the upper side of the inner edge 247. The cover disc 259 defines an annular protrusion 263, and the cover disc defines an annular protrusion 263. annular recess 265 for receiving therein the annular protrusion of the cover and thereby firmly securing the cover disc thereto. The cover disc 259 is fixedly secured to the cover after needle penetration and thermal resealing of the cap region 253 to thereby prevent access to the cap and provide an added barrier to prevent transmission of moisture, vapor, or gas through the cap. of the plug. In Figures 10-13 another assembly representing the present invention is generally indicated by the reference numeral 310. The assembly 310 is similar in many respects to the assembly 210 described above with reference to Figures 7-9, and therefore numbers Similar references preceded by the number "3" instead of the number "2" are used to indicate similar elements. As shown in Figure 10, the one-way valve assembly 312 includes a manually engageable, shaped actuator. of dome 315 for distributing substantially measured amounts of fluid from a bag 322 (Figure 14) defining a variable volume storage chamber 324 through the valve. The valve assembly 312 includes an integral rigid tube 314 that defines at an upstream end thereof a mounting edge 317 for mounting the tube and valve assembly to a relatively rigid box 325 that contains therein the flexible bag 322 (Figure 14). The box 325 and the bag 322 may be the same as or substantially similar to the box and bag described above., or they can be made of any of numerous different materials, and / or they can take any of many different forms and / or configurations that are currently known or will be known later. The dome-shaped actuator 315 is made of an elastomeric material that is flexible and can be manually engaged and pressed in to operate the actuator and thereby pump fluid from the variable volume storage chamber 324 through the one-way valve 312. As shown in Figure 11, the one-way valve 312 includes a projection 317 extending inwardly from the actuator 315, a valve body 330 defining a compression chamber 332 for receiving therein from the air chamber. variable volume storage 324 each dose or separate portion or service of fluid to be dispensed, a relatively rigid valve seat 334, and at least one flow opening 336 extending through the valve body 330 adjacent to the valve group 334 and coupled in fluid communication with the compression chamber 332. The one-way valve assembly 312 also includes a valve cover ula 338 formed of an elastic material and including a cover base 340 mounted on the valve body 330 and securely secured against axial movement relative thereto, and a valve portion 342 that covers the valve seat 334. The valve portion 342 and valve body 330 form an interference fit between them. As can be seen, valve portion 342 and valve seat 334 define a normally closed, axially extending valve opening 344 therebetween. The valve portion 342 is radially movable between a normally closed position, as shown, with the valve portion 342 that couples the valve seat 334, and an open position (not shown) with at least one segment of the valve portion. 342 spaced radially away from the valve tape 334 to connect the valve opening 344 in fluid communication with the flow opening 336 and thereby allow the passage of fluid from the compression chamber 332 to the flow opening 336 and through of the valve junction 344. The one-way valve 312 also includes an inlet passage 348 that extends through the tube 314 and engages in fluid communication with the variable volume storage chamber 324 (Figure 12). The one way valve 312 can be connected directly to the variable volume storage chamber 324 and then welded or otherwise sealed to the bag 322 to prevent contaminants from entering the compression chamber or valve. Alternatively, the inlet passage 348 can be coupled to a flexible tube of the type shown, for example, in Figure 2, the flexible tube can, in turn, connect the valve 312 to the storage chamber 324. As can be seen, in its normally closed position, the projection 317 separates the compression chamber 332 from the inlet passage 348 and storage chamber 324. Thus, during the downward stroke of the dome-shaped actuator 315, as indicated by the arrow in Figure 11, the projection 317 prevents fluid within the compression chamber 332 from flowing back into the entry opening 348 in the variable volume storage chamber 324, and in turn allows the manually depressed actuator to press the fluid in the compression chamber sufficiently to overcome the valve opening pressure and distribute through the valve. Then, during the upward or backward stroke of the dome-shaped actuator 315, the suction force or vacuum created within the compression chamber causes the projection 317 to flex away from the entry opening, as indicated by the arrow in Figure 11, to thereby place the compression chamber 332 in fluid communication with the inlet passage 348 and allow the next dose of fluid to flow into the compression chamber. The valve assembly 312 can otherwise be constructed in accordance with the teachings of the commonly assigned patent applications, co-slopes incorporated by reference above. According to such teachings, at least one of the valve seat diameter D2 (as shown in Figure 11, the valve seat defines a gradually descending diameter when moving from the upstream to the downstream current end of the valve seat. valve seat), the degree of interference between the valve portion 342 and the valve seat 334, the predetermined radial thickness of the valve portion 342, and a predetermined modulus of elasticity of the valve cover material 338, is selected for (1) defining a predetermined valve opening pressure generated by depressing the dome-shaped actuator 315 that allows passage of fluid from the compression chamber 332 through the normally closed valve opening 344, and (2) hermetically sealing the valve 312 and prevent the ingress of bacteria or other contaminants through the valve opening 344 and into the passage 348 in the normal position you closed. In the illustrated embodiment of the present invention, each of the valve seat diameter D2, the degree of interference between the valve portion 342 and the valve seat 334, the predetermined radial thickness of the valve portion 342, and the module The elasticity preset of the valve cover material 338 is selected to (i) define a predetermined value of aperture pressure generated by depressing the actuator 315 allowing passage of a substantially predetermined volume of fluid from the reservoir 324 to the chamber 332 and through the valve opening 344; and (2) hermetically sealing the valve opening 344 and preventing the ingress of bacteria or other contaminants through the valve opening in the normally closed position. The valve assembly 312 further includes a protective cover or shield 366 (not shown in Figure 10) extending annularly over the flexible valve cover 338, and extending axially from the base of the valve cover 338 toward an adjacent point to the valve distribution point but spaced axially inward thereof. The shield 366 is mounted to the valve body 330 and includes a peripheral edge 367 that integrally engages a corresponding peripheral edge 369 the dome-shaped actuator 315 to securely secure the dome-shaped actuator to the valve body, and includes a lower annular rim 371 which compressively engages the cover base 340 of the valve cover to securely secure the valve cover to the valve body. The one-way valve assembly 312 operates as follows. The dome-shaped actuator 315 is pressed downward, such as a manual coupling, to pressurize and in turn displace a substantially predetermined volume of fluid located within the compression chamber 332. The resulting fluid pressure within the compression chamber 332 It causes the projection 317 to seal itself against the valve body wall surrounding the inlet passage 348 to thereby prevent fluid communication between the inlet passage and the compression chamber. If desired, the projection 317 and / or the wall surrounding the entry passage 348 can be angled to help create a seal between the projection and the wall. A substantially predetermined volume of fluid then moves from the compression chamber 332 through the flow opening 336, towards the valve seat 334, and out through the valve opening 344. When the actuator 315 is pressed downwardly , the chamber 332 empties or empties substantially. When the user releases the actuator 315, a vacuum is created within the chamber 332 and the protrusion swings out of the passage 348, as indicated by the date in Figure 11, which allows the fluid to flow from the reservoir 324 in the compression chamber 332. If desired, and as typically shown in Figure 13, the valve body 330 may include an arm 319 that is spread down from, and adjacent the projection 317 at a distance sufficient to define a space 321 between the arm and the projection when the projection is located in the normally closed position. The arm 319 operates as a plug to prevent further downward movement of the projection thereby preventing the projection from swinging out of position. As shown, the arm 319 can define one or more flow openings through itself to allow the fluid to flow freely when the projection is in the open position. As shown in Figures 12, 13 and 14, the valve and tube assembly can further include a stopped cover or cover 321 spaced radially outwardly of the tube 314 to cover the tube and, if desired, support the valve and the tube assembly against the box 325 (Figure 10). As can be recognized by those skilled in the pertinent art based on the teachings herein, the actuator 315, and the compression chamber 332 can take any of many different shapes and / or configurations, and / or can be formed from any of a number of different materials that are currently known, or will be known later to perform the functions of these components. For example, the compression chamber 332 may define a curvilinear shape to facilitate coupling between the underside of the dome-shaped actuator and the compression chamber in the downward stroke of the actuator. Similarly, the downward side of the actuator may form a more traditional piston shape, such as a cylindrical protrusion, slidably received within a correspondingly shaped compression chamber. In addition, the actuator may include a lever or other operator that is manually engageable to press the actuator and, in turn, distribute measured quantities or substantially measured amounts of fluid from the variable volume storage chamber and through the one-way valve . In an alternative embodiment shown in Figure 15, the variable volume storage chamber 324 is not defined by a flexible bag mounted within a box as described above with reference to Figures 7-14, but rather is defined by a relatively rigid tubular body 322. A plunger 325 is slidably mounted within the tubular body 322 and forms a fluid-tight seal between the peripheral surface of the plunger and the inner wall of the tubular body. As can be seen, the variable volume storage chamber 324 is formed between the plunger 325 and the inlet passage 348 to the valve assembly 312. The tubular body 322 includes an end cap 367 defining a fluid flow opening 369 in it to allow air to flow freely through it and thereby allow the plunger 325 to slide inwardly inside the tubular body 322 by distributing fluid from the variable volume storage chamber 324. In this embodiment, the vacuum created within the compression chamber 332 at the upward or backward stroke of the dome-shaped actuator 315 extracts fluid from the variable volume storage chamber 324 and, in turn, causes the plunger 325 to move inwardly toward the inlet passage 348 and adjusts correspondingly to the volume of the storage chamber to compensate for fluid distribution. The apparatus and methods for pre-sterilizing the sealed, empty bag, the tube and assembly assemblies, for assembling the plug to the bag or other container, and / or for filling the needle aseptically from the sterilized bag, tube assemblies and Valve through penetrable needle and laser resealable stops, may take the form of any apparatus and methods described in the following commonly assigned patents and patent applications that are hereby expressly incorporated by reference as part of the present disclosure: Application of US patent Series No. 10/766, 172, filed January 28, 2004, entitled "medicament bottle having a heat-sealable lid, and apparatus and method for filling the flask", which is a continuation in part of the similarly titled US Patent Application. No. 10 / 694,364, filed on October 27, 2003, which is a continuation of the US Patent Application co-pending similarly titled Series 10 / 393,966, filed March 21, 2003, which is a divisional of the U.S. Patent Application. similarly entitled Series No. 09 / 781,846, filed on February 12, 2001, now Patent of E.U.A. No. 6,604,561, issued August 12, 2003, which, in turn, claims the benefit of the provisional Application of E.U.A. similarly entitled Series No. 60 / 182,139, filed on February 11, 2000; and Provisional patent application of E.U.A. No. 60 / 443,526, filed January 28, 2003, and Provisional Patent Application of E.U.A. similarly titled 60 / 484,204, filed on June 30, 2003; Patent application of E.U.A. No. 10 / 655,455, entitled "Sealed Containers and Methods for Making and Filling the Same", filed on September 3, 2003, which, in turn, claims the benefit of the provisional patent application E.U.A. similarly entitled No. 60 / 408,068 filed September 3, 2002; Provisional patent application of E.U.A. No. 60 / 551,565, filed March 8, 2004, entitled "Apparatus and Method for Molding and Assembling Containers with Caps"; Patent application of E.U.A. Series No. 10 / 600,525 filed on June 19, 2003 entitled "Sterile Filling Machine having Needle Filling Station inside the E-Ray Chamber", which in turn, claims the benefit of the provisional Application of E.U.A. similarly entitled No. 60 / 390,212 filed on June 19, 2002; Patent application of E.U.A. Series No. 10 / 983,178 filed November 5, 2004 entitled "Needle Filling and Laser Sealing Station", which, in turn, claims the benefit of the provisional patent application of E.U.A. similarly titled No. 60 / 518,267 filed on November 7, 2003 and provisional patent application E.U.A. similarly titled No. 60 / 518,685 filed November 10, 2003; Provisional patent application E.U.A. No. 60 / 550,805 filed on March 5, 2004 entitled "Apparatus for Filling by Needle and Laser Resealing"; and Patent Application E.U.A. No. 08 / 424,932 filed on April 11, 1995, now Patent of E.U.A. No. 5,641,004 issued June 24, 1997 entitled "Procedure for Filling a Sealed Receptacle under Aseptic Conditions". In the presently preferred embodiments of the present invention, each resealable plug is formed of a thermoplastic material that defines a needle penetration region that is pierceable with a needle to form a needle opening therethrough, and can be resealed by heat to seal tightly the needle opening by applying laser radiation at a predetermined wavelength and energy thereto. Each plug includes a thermoplastic body that defines (i) a predetermined wall thickness in an axial direction thereof, (ii) a predetermined color and opacity that substantially absorb laser radiation at the predetermined wavelength and substantially prevents passage of the radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity which causes the laser radiation at the predetermined wavelength and energy to hermetically seal the needle aperture formed in the needle penetration region of the needle. the same in a predetermined period of time and substantially without burning the needle penetration region and / or the cover portion of the cap (ie, without creating a reversible change in the molecular structure or chemical properties of the material). In some embodiments, the predetermined time period is about 2 seconds, preferably is less than or equal to about 1.5 seconds, and is preferably not less than or equal to about one second. In some of these embodiments, the predetermined wavelength of the laser radiation is about 980 nm, and the predetermined energy of each laser is preferably less than about 30 watts, and preferably less than or equal to about 10 watts, or inside the scale from about 8 to about 10 watts. Also in some of these embodiments, the predetermined color of the material is gray, and the predetermined opacity is defined by a dark gray colorant (or pigment) added to the plug material in an amount within the range of from about 0.3% to about 0.6% in weigh. In addition, if desired, the lubricant of a type known to those skilled in the art can be added to or included within each of the aforementioned thermoplastic composites., in order to prevent or otherwise reduce the formation of particles by penetrating the needle penetration region or the thermoplastic region with the needle. In one embodiment, the lubricant is a mineral oil that is added to the styrene block copolymer or other thermoplastic compound in an amount sufficient to prevent, or substantially prevent, the formation of particles upon penetration by the needle or other filler material . In another embodiment, the lubricant is a silicone, such as liquid silicone sold by Dow Corning Corporation under the designation "360 Medical Fluid, 350 CST", or a silicone oil, which is added to the block copolymer of styrene or other compound thermoplastic in an amount sufficient to prevent, or substantially prevent, the formation of particles when penetrating the same with the needle or other filling material. In such an embodiment, the silicone oil is included in an amount within the range of about 0.4% to about 1% by weight, and preferably within the range of about 0.4 to about 0.6% by weight, and most preferably within the range of scale from about 0.51 to about 0.5% by weight. As described above, the configuration of the needle that is penetrating the plug, the friction forces created in the needle / plug interface, and / or the needle stroke through the plug can also be controlled to further reduce or substantially prevent the formation of the particles when penetrating the stops with the needles. Also according to a currently preferred embodiment, the laser-resealable, needle-penetrable cap comprises: (i) a styrene block copolymer, such as any such styrene block copolymers described above, within the scale of about 80 % to about 97% by weight (eg, 95% by weight as described above); (ii) an olefin, such as any of the ethylene alpha olefins, polyolefins or olefins described above, within the range of about 3% to about 20% by weight (eg, about 5% as described above); (iii) a pigment or dye added in an amount sufficient to absorb the laser energy, convert the radiation to heat, and fuse the plug material, preferably to a depth equal to about 1/3 to about 1/2 the depth of the needle hole, within a period of time less than about 3 seconds, more than preferably less than about 1-1 / 2 seconds, and most preferably less than about 1/2 seconds; and (ID) a lubricant, such as a mineral oil, liquid silicone, or silicone oil as described above, added in an amount sufficient to substantially reduce frictional forces at the needle / plug interface during penetration of the stopper needle to, in turn, substantially prevent particle formation. In one embodiment of the invention, the pigment is sold under the tradename Lumogen ™ IR 788 by Aktiengesellschaft of Ludwiggshafen, Germany. The products of Lumogen IR are highly transparent selective near infrared absorbers designed for radiation absorption of semiconductor lasers with wavelengths near approximately 800 nm. In this embodiment, the Lumogen pigment is added to the elastomeric mixture in an amount sufficient to convert the radiation to heat, and melt the plug material, preferably at a depth equal to at least about 1/3 to about 1/2 of the depth of the needle hole, within a period of time of less about 3 seconds, more preferably less than about 1-1 / 2 seconds, and most preferably less than about 1/2 seconds. The Lumogen IR 788 pigment is highly absorbent at approximately 788 nm, and therefore in connection with this embodiment, the laser preferably transmits radiation at approximately 788 nm (or approximately 800 nm). An advantage of the Lumogen IR 788 pigment is that very small amounts of this pigment can be added to the elastomeric mixture to achieve laser resealing with the time periods and at the required or otherwise desired depths of resealing, and therefore, if If desired, the needle-penetrable or laser resealable cap can be transparent or substantially transparent. This can be a significant aesthetic benefit. In one embodiment of the invention, the Lumogen IR 788 pigment is added to the elastomeric mixture at a concentration of less than about 150 ppm, preferably it is within the range of about 10 ppm to about 100 ppm, and most preferably is within the range of scale from approximately 20 ppm to approximately 80 ppm. In this embodiment, the laser energy level of 800 nm is preferably less than about 30 watts, or within the range of about 8 watts to about 18 watts. Also, in accordance with a currently preferred embodiment, in addition to controlling one or more of the aforementioned parameters to reduce and / or eliminate particle formation (i.e., including silicone oil or other lubricant in the thermoplastic compound, and control the needle configuration, the degree of friction in the needle / plug interface, and / or the needle stroke through the cap), the differential elongation of the thermoplastic components of the cap is selected to reduce and / or eliminate the formation of particles. Thus, according to such embodiment, the penetrable needle and the needle-resealable cap comprises: (i) a first thermoplastic material within the range of about 80% to about 97% by weight and which defines a first elongation; (ii) a second thermoplastic material within the range of about 3% to about 20% in weight and which defines a second elongation less than the elongation of the first material; (ii) a pigment or dye added in an amount sufficient to absorb the laser energy, convert the radiation to heat, and melt the plug material, preferably to a depth equal to about 1/3 to about 1/2 the depth of the needle hole, within a period of time less than about 2 seconds, more preferably less than about 1.5 seconds, and most preferably less than about one second; and (iv) a lubricant, such as a mineral oil, liquid silicone, or silicone oil as described above, added in an amount sufficient to substantially reduce frictional forces in the needle / plug interface during penetration of the stopper needle. to, in turn, substantially prevent particle formation. According to a further aspect, the first material defines a lower melting point (or Vicat softening temperature) to the second material. In some of the embodiments, the first material is a styrene block copolymer, and the second material is an olefin, such as any of a variety of ethylene alpha-olefins or polyolefins. Also according to a currently preferred embodiment, the first material defines an elongation of at least about 75% at a force of 4.53 kg (ie, the length increases by approximately 75% when subjected to a 4.53 kg door), preferably at less about 85%, and most preferably at least 90%; and the second material defines an elongation of at least about 5% by force of 4.53 kg, preferably at least about 10%, and most preferably at least about 15%, or within the range of about 15% and about 25%. In Figures 16, 18, another assembly representing the present invention is generally indicated by the reference numeral 410. The assembly 410 is similar in many respects to the assemblies 210 and 310 described above with reference to Figures 7-15, and therefore similar reference numbers preceded by the number "4" instead of the numbers "2" or "3" are used to indicate similar elements. The variable volume storage chamber 424 is defined by a flexible bag 422 received within a relatively rigid box or other appropriately shaped container 425. An entire 414 defining an input passageway 448 is coupled in fluid communication between the camera variable volume storage 424 and compression chamber 432. A substantially dome-shaped pump or elastic actuator 415 defines on its inner side a compression chamber valve member 417 that forms a narrowed cross-sectional configuration tapering downwardly of the free end of the valve member. In the downward stroke of the dome-shaped actuator 415, indicated by the arrow in Figure 16, the free end of the compression chamber valve member 417 is received within the inlet passage 448 of the tube 414 to thereby prevent that any additional fluid flows from the storage chamber 424 into the compression chamber 432 and, in turn, pressurize sufficiently with the additional manual compression of the dome-shaped actuator 415 the fluid within the compression chamber 432 to overcome the valve opening pressure and to distribute a substantially predetermined amount of fluid through the one-way valve 412. On the return or upward stroke of the dome-shaped actuator 415, the free end of the valve member 417 is pulled down and out of the inlet passage 448 of the tube 414 to, in turn, place the compression chamber 432 in fluid communication with the storage chamber olume variable 424 and thereby allow fluid to flow from storage chamber 424 into compression chamber 432. Bag 422 is flexible enough to decrease in internal volume by an amount corresponding to the amount of fluid flowing from the chamber of storage 424 in the compression chamber 432 at the return stroke of the dome-shaped actuator 415. Preferably, the dome-shaped actuator 415 is configured to retain sufficient spring force when the downward stroke of the same is pressed inward to also pull up and back to the ready position as typically shown in Figure 16 when manually released . The one-way valve assembly 412 includes a valve body 430 which defines an axially extending valve seat 434, and an elongate flow opening 436 formed within the valve body 430 and extending in fluid communication between the valve body 430. compression chamber 432 and valve seat 434. The one-way valve assembly 412 further includes a valve cover 438 formed of an elastic material integral with the dome-shaped actuator 415. The valve cover 438 includes a base of cover 440 mounted on the valve body 430 and securely secured against relative movement thereto by an edge 467 of a relatively rigid adjusting ring 466, and a valve portion 442 that covers the valve seat 434. As shown in FIG. Figure 18, the valve portion 442 is arcuate in shape when viewed in a plane perpendicular to the elongated axis "X" of the assembly, and as typically shown in FIG. Figure 16, when viewed in a plane of the elongated shaft X, valve portion 442 defines a substantially tapered cross-sectional configuration tapering inwardly when moving in a direction from the inside to the outside of the valve (or from the base to the tip of the valve distribution). The valve portion 442 defines a predetermined radial thickness that is progressively more delegated when moving in the direction from the inside to the outside of the valve (or from the base to the valve dispensing tip). As shown in Figure 16, the inner surface of the valve cover 442 is defined by a first variant radius R1 that progressively increases in magnitude as it moves in the direction from the base to the dispensing tip of the valve cover, and the outer surface of the valve seat 434 is defined by a second variant radius R2 which similarly increases progressively in magnitude as it moves in the direction from the base towards the dispensing tip of the valve seat. Similar to the one-way valves described above, for each coupled segment of the valve cover and the valve seat, R2 is larger than R1 to thereby form an interference fit between the valve cover and the valve seat. Accordingly, as with the one-way valves described above, the flexible valve portion 442 and the valve seat 434 cooperate to define a normally closed, axially extending valve opening 444 therebetween. Also similar to the one-way valves described above, the valve portion 442 is movable radially between a normally closed position, as shown in Figure 16, with the valve portion 442 that engages the valve seat 434, and a open (not shown) with at least one segment of the valve portion 442 spaced radially away from the valve seat 434 to connect the valve opening 444 in fluid communication with the flow opening 436 to thereby allow the passage of fluid from the flow opening 436 through the valve opening 444. As typically shown in Figure 18, the valve portion 442 is substantially semi-circular when viewed in a plane perpendicular to the elongated axis x of the assembly. As indicated in Figure 16, the valve seat 434 corresponds in shape and extension to the valve portion 442 to thereby form the normally closed valve opening, axially extending 444 therebetween. As can be recognized by those skilled in the relevant art based on the teachings here, the shape of the valve seat and the valve portion, which includes the arched extension of each such component may vary from that shown herein as desired or otherwise dictated by the application of the assembly and the desired performance characteristics. As shown in Figure 17, the adjusting ring 466 includes opposite adjustment edges 469 which couple corresponding side portions of the valve seat 434 to securely lock the adjusting ring to the valve seat, and in turn, firmly retain the cover of the valve seat. valve and the valve portion between them. As shown in Figure 16, the tube 414 is integrally formed at one end thereof with a base wall 471 of the compression chamber 432, and is formed integral at another end thereof with an edge 473 securely secured to the bag 422 The base wall 471 of the compression chamber 432 is received within an opening 475 of the container 425, and includes a peripheral edge 477 sealedly coupled within an annular recess 479 of the container. Adjustment ring 466 defined a peripheral adjustment edge 481 which engages the inner side of a peripheral edge 483 of container 425 to compress peripheral edge 469 and cover base 440 between the adjusting ring and the container edge to a preload comprehensively substantially predetermined to prevent any escape through the shelf life and use of the assembly, and thereby firmly secure together the integral dome-shaped actuator assembled and the valve cover, tube and bag assembly, and container. In the operation of the assembly 410, a user distributes a substantially predetermined amount of fluid through the one-way valve 412 by manually engaging the dome-shaped actuator 415, for example, with one or more fingers or the palm of a hand , and press the dome-shaped actuator down. In the downward or inner stroke of the actuator, the free end of the compression chamber valve member 417 is received within the outlet opening 448 of the tube 414 to thereby block the flow of any fluid between the compression chamber 432 and the storage chamber 424. Then, while the dome-shaped actuator 415 is further depressed, the fluid within the compression chamber 432 is pressurized sufficiently to exceed the valve opening pressure of the one-way valve 412 and , in turn, open the valve and distribute substantially all the fluid within the compression chamber through the valve. The user then removes his hand from the dome-shaped actuator 415, and the inherent spring force within the elastic dome-shaped actuator driving the actuator to return to its original shape or ready position as typically shown in Figure 16. While the dome-shaped actuator 415 returns to its ready position, the free end of the compression chamber valve member 417 is removed from the inlet passage 448 which, in turn, allows the fluid to be drawn upwards from the storage chamber in the compression chamber due to the vacuum or suction created inside the compression chamber in the upward stroke of the dome-shaped actuator. When the dome-shaped actuator 415 returns to its original position, the compression chamber 432 is filled with fluid and the assembly is ready to distribute another predetermined volume of fluid. Although not shown, the box 425 may define at least one vent to allow air to flow in the space between the bag 422 and the box 425 to facilitate the bag's ability to bend inwardly on itself by distributing fluid therefrom. . As can be recognized by those skilled in the pertinent art based on the teachings herein, the dome-shaped bag or actuator may include a needle-penetrable and laser-resealable cap or other portion for needle refilling of the variable volume storage chamber. and laser re-sealing the resulting needle hole as described above. The bag 422 and the box 425 can be made from the same materials as the bag and box described above, respectively, or can be made from any of numerous other materials that are currently known, or will be known later. For example, box 425 can be made of plastic, such as by blow molding or thermoforming. In addition, the one-way valve 412 may define a configuration that is the same as or more similar to any of the one-way valves described above in connection with the other embodiments. In Figure 19, another apparatus embodying the present invention is generally indicated by the reference numeral 510. The apparatus 510 is similar in many aspects to various embodiments described above, and therefore similar reference numbers preceded by the numeral "5", or preferred by the number" 5"instead of another number, are used to indicate similar items. The primary difference of the apparatus 510 compared to the apparatus described above is that the apparatus 510 includes a bladder or expandable bag 522 mounted within a relatively rigid container 528 and defining a storage chamber of variable volume 524 therebetween to store therein the fluid to distribute. Preferably, the fluid is stored in the chamber 524 in a substantially airless condition, hermetically sealed through the life at instant and use of the apparatus (i.e., through the distribution of multiple doses or portions of the product from the apparatus) . An inlet port 525 is coupled in fluid connection between an inner chamber 527 of the expandable bladder 522 in order to allow air or other gas to flow into the inner chamber 527, in turn, to allow the bladder 522 to be expands outwardly of the distribution fluid of the variable volume storage chamber 524 and through the one-way valve assembly 512. In one embodiment, the expanded bladder 522 is inherently flexible and deviates outwards to expand itself outwardly to the outside. distributing fluid from the variable volume storage chamber 524. In another embodiment, the apparatus includes an inlet valve 529 coupled in fluid communication between the inner chamber 527 of the bag and the ambient atmosphere and / or a source of pressurized gas ( not shown) to control the flow of air or other gas in the inner chamber 527. In such mode, the pressurized gas is introduced through the inlet valve. to 529 and in the inner chamber 527 to pressurize the expandable bladder 522 outwardly and, in turn, pressurize the fluid into the variable volume storage chamber 524 to facilitate fluid distribution through the one-way valve assembly 512 In the illustrated embodiment, the apparatus includes a manually actuated actuator 515 for pumping measured portions or doses of fluid through the valve assembly 512. However, as can be recognized by those skilled in the pertinent art based on the teachings herein , any of numerous manually-actuated, pedal-operated, electrically operated, or electromechanically actuated pumps currently known, or the last ones known, may also be employed. In Figure 20, another apparatus embodying the invention is generally indicated by the reference number 610. The apparatus 610 is similar in many respects to various embodiments described above, and therefore similar reference numbers preceded by the number "6" , or preferred by the number "6" instead of another number, are used to indicate similar elements. The primary difference of the apparatus 610 compared to the apparatus described above is that the apparatus 610 does not include a bladder or flexible bag defining a storage chamber of variable volume, but more than that the storage chamber 624 is defined by the inside of the container 628. A sterilization filter 631 is mounted in container 628 and is coupled in fluid connection between storage chamber 624 and ambient atmosphere to allow air or other gas to flow in storage chamber and sterilize air or other gas with the passage through the filter to thereby keep the fluid product in the container in an aseptic condition. The 631 filter can take the form of any of many different filters that are currently known, or that will be known later to perform the function of the filter 631, which includes a microbial filter. One such filter defines a size of less than about 10 microns, preferably less than about 5 microns, and most preferably less than or equal to about 2 microns. The container 628 may be rigid, semi-rigid, or flexible, and may be made of any of a number of different materials, or may be formed in any of numerous different shapes or configurations, which are currently known or will be known later. In the illustrated embodiment, the apparatus includes a manually engageable actuator 615 for pumping measured portions or fluid doses through the valve assembly 612. However, as can be recognized by those skilled in the pertinent art based on the teachings herein, any of different manually-actuated, pedal-operated, electrically-driven, or electro-magnetically actuated pump numbers that are currently known, or will be known later, may also be employed. In Figure 21, another apparatus embodying the present invention is generally indicated by the reference number 710. The apparatus 710 is similar in many respects to various embodiments described above, and therefore similar reference numbers preceded by the number "7", or preceded by the number" 7"instead of another number, are used to indicate similar elements. As with several embodiments described above, the apparatus 710 includes a flexible bag 722 defining a variable volume storage chamber 724, a one way valve assembly 712, and a flexible tube 714 coupled in fluid communication between the valve of a address and storage chamber. An inlet valve 729 is mounted in the container 728 and is connectable in fluid communication between a source of pressurized fluid, such as air or other gas, and the inner chamber 727 formed between the flexible bag 722 and the relatively rigid container 728. In one embodiment, the pressure source 733 introduces pressurized air or other gas into the chamber 727, in turn, to pressurize the bag 722 and the fluid product contained within the bag. A valve 715 of a type known to those skilled in the pertinent art is movable between (i) a closed position in which it pierces the flexible tube 714 in a closed position to prevent the passage of fluid therethrough, and (ii) an open position in which it releases the flexible tube 714 and allows the passage of fluid through it. In the open position, the pressurized gas within the chamber 727 creates sufficient pressure to move the fluid product through the one way valve 712. The valve 715 can be manually engaged to open and close the valve, or it can be electrically operated or the electromechanically between the open and closed positions. In one embodiment, the container is initially filled with pressurized gas, and this amount of pressurized gas is sufficient to distribute all the fluid product through the valve. In another embodiment, the pressure source 733 may take the form of a pump pumping air and pressurized or other gas into the chamber 727 to distribute product through the one-way valve. In this embodiment, valve 715 can be eliminated and pump 733 can be operated to distribute fluid through the valve. Also in this embodiment, the pump 733 can take the form of any of the numerous manually adjustable, pedal-operated, electrically-operated, or electromechanically driven pumps that are currently known, or will be known later.

In Figure 22, another apparatus representing the present invention is generally indicated by the reference numeral 810. The apparatus 810 is similar in many respects to several embodiments described above, and therefore similar reference numbers preceded by the number "8", or preceded by the number" 8"instead of another number, are used to indicate similar elements. As with several embodiments described above, the apparatus 810 includes a flexible bag 822 defining a variable volume storage chamber 824, a one-way valve assembly 812, and a flexible tube 814 coupled in fluid communication between the valve of a address and storage chamber. The apparatus 810 comprises a manually operated peristaltic pump 815 mounted adjacent to and engageable with the flexible tube 814 for pumping measured pons or fluid product doses from the variable volume storage chamber 824 through the tube 814 and one-way valve assembly 812. In the illustrated embodiment, the pump 815 is operated manually or by pedal, and comprises a rotatably mounted peristaltic pumping member 835 that includes a plurality of rollers 837 mounted on the periphery thereof to rotatably engage the flexible tube 814 and compress the tube in turn to pump the fluid product through it. A rigid pump block, curvilinearly shaped 839 is mounted on the opposite side of the flexible tube 814 relative to the peristaltic pump member 835 to allow the rollers 837 to compress the flexible tube 814 against the block and pump the fluid product through of this. A link assembly 841, such as the illustrated multiple bar link, is conductively connected to the peristaltic pump member 835 to rotationally drive the pump member. A manually engageable lever or foot pedal (not shown) is connected by conduction to the link 841 to drive the link and, in turn, rotatably drive the peristaltic pump member 835 to pump measured pons of fluid product from the storage chamber of variable volume 824 through the one-way valve assembly 812. The flexible bag, tube and valve assemblies are provided in a disposable form so that they are discarded when empty; however, the container 810 and the pump 815 normally do not touch the fluid product and can therefore be reused with numerous different bags, tube and valve assemblies, or the like can be provided in disposable form. In Figure 23, another apparatus embodying the present invention is generally indicated by the reference numeral 910. The apparatus 910 is similar in many aspects to various embodiments described above, and therefore similar reference numbers preceded by the numeral "9", or chaired by the number" 9"instead of another number, are used to indicate similar elements as with the various embodiments described above, the apparatus 910 includes a flexible bag 922 defining a storage chamber of variable volume 924, an assembly one-way valve 912, and a flexible tube 914 coupled in fluid communication between the one-way valve and storage chamber. In the illustrated embodiment, the pump 915 is operated manually or by pedal, and comprises the pump block 939 mounted on one side of the flexible tube 914, and an oscillating arm 935 pivotally mounted on the opposite side of the flexible tube. As indicated by the arrow and the lines divided in the drawing, the oscillator arm is manually operated downwardly in the pattern to couple the flexible tube 914 and, in turn, compress the tube to pump measured pons or fluid product doses. through these. The oscillator arm 935 can be manually coupled as well, or a manually engageable lever or other actuator can be coupled to the rocking chair to move the oscillating arm in the indicated manner and, in turn, pump measured pons of fluid product through the valve of an address. The flexible bag, tube and valve assemblies are provided in a disposable form so that they are discarded when they are emptied; however, the container 810 and the pump 815 normally do not touch the fluid product and can therefore be reused with numerous different bags, tube and valve assemblies, or the like can be provided in disposable form. An advantage of the present invention is that the same product by itself can be self-stable in the bag, whether refrigerated or not, through the shelf life and use of the bag. Accordingly, the present invention is particularly suitable for storing and disposing of ready-to-drink products, including non-acidic products, such as those which are generally difficult to preserve with the opening of the package, including without limitation, beverages such as wine, beverages containing milk, cocoa-based beverages, milkshake-based beverages, tea, coffee, coffee concentrate, tea concentrate, other concentrates to be beverages or food products, sauces, such as cheese and milk, or food-based sauces, dressings, soups, and nutritional drink supplements, meat replacements, baby formulas, milks, growth milks, etc. Accordingly, a significant advantage of the presently preferred embodiments of the present invention is that they allow the aforementioned and any of numerous other products to be distributed and stored at an ambient temperature and allow the product to remain shelf-stable even after the product is dispensed. of the bag, whether refrigerated or not. However, for certain products it may be desirable to refrigerate the product to provide a better flavor, to provide the product at a desired or adapted temperature, or for numerous other reasons that are currently known or will be known later. This patent application contains the subject related to that described in the patent application of E.U.A. series No. 11 / 295,274, filed December 5, 2005, entitled "Valve of a Direction and Apparatus Using the Valve", Patent Application of E.U.A. Series No. 11 / 295,251, filed on December 5, 2005, entitled "Method for Using a Directional Valve and Related Sparatus", Provisional Patent Application E.U.A. Series No. 60 / 633,332, filed on December 4, 2004, Provisional patent application E.U.A. Series No. 60 / 644,130, filed on January 14, 2005, both entitled "Valve of a Direction, Apparatus and Method for Using the Valve", Provisional patent application of E.U.A. Series No. 60 / 757,161, filed January 5, 2006, and provisional patent application of E.U.A. Series No. 60 / 843,131, filed on September 9, 2006, both entitled "Valve of a Direction and Apparatus and Method to Use the Valve". Each of the above patent applications which are incorporated herein by reference in their entirety as part of the present disclosure.

As can be recognized by those skilled in the pertinent art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present invention without departing from the spirit of the invention as defined in the claims. For example, the components of the apparatus can be made of any of numerous different materials that are currently known, or will be known later to perform the function (s) of each component. Similarly, the components of the apparatus can take any of different shapes and / or cgurations, additional components can be added, components can be combined, and one or more components or features can be removed.

In addition, the apparatus can be used to distribute any of numerous different types of fluid or other substances for any of a number of different applications, including, for example, nutritional, food, beverage, hospital, biopharmaceutical, bioprocessing and pharmaceutical applications. For example, the dispenser may take the form of an automated food or beverage dispenser of the type described in the U.S. Patent Application. Series No. 10 / 328,826, filed December 24, 2002, entitled "Clean Automated Food or Beverage Distributor in Place" (Publication No. U S2004 / 0118291 A1), or US Patent Application. Series No. 10 / 833,110, filed on April 28, 2004, entitled "Clean Automated Food or Beverage Distributor in Place" (Publication No. US2004 / 0194811 A1), each of which is expressly incorporated herein by reference as part of the present description. In this illustrative application, the tube and valve assembly of a direction described herein replaces the tube and the puncture valve engaged between the reservoir and the manifold. Alternatively, the one-way valve tube and bag assemblies described herein replace each associated puncture and reservoir tube and valve described in such patent applications. A significant advantage of this application is that the valve of one direction substantially prevents any of the microorganisms from entering the reservoir that may contain a milk-based product, which also allows the product based on which to be distributed at room temperature without require refrigeration of the container. In addition, the one-way valve, bagpipe assembly can be used to store any of the numerous different products to be dispensed, such as milk-based products, which include milk concentrate, half and half, and others of creams, food for baby or formulas, milks for growth, other liquid nutrition products, coffee, coffee concentrate, tea, tea concentrate, syrup, such as chocolate syrup for hot chocolate, cappuccino syrups, or other beverage mixtures or syrups, coffee aroma to distribute a "fresh" coffee aroma at the time of, or substantially at the same time, distributing coffee, or other dairy products such as yogurt and ice cream, or non-dairy products, such as juice, soy-based products, nutritional supplementary beverages, functional food products, beverage mixes, or food replacement beverages. In addition the filling machines used to fill tanks used with the apparatus of the present invention can take any of numerous different cgurations that are currently known, or which will be known later to fill the tanks, bags or dispensers. For example, filling machines can take any of numerous different mechanisms for sterilizing, feeding, evacuating and / or filling the one-way valve, tube and bag assemblies, or otherwise to fill the reservoirs. Furthermore, rather than using the needle-penetrable and resealable cap, the reservoir may employ a filling valve as described in the following patent application which is assigned to the Representative of the present invention., and is incorporated herein by reference as part of the present disclosure: Application of E.U.A. Series No. 10 / 843,902, filed on May 12, 2004, entitled "Distributor and Apparatus and Method for Filling a Distributor". In such alternative embodiments, the fill valve may extend through the bag or otherwise be coupled in fluid communication with the storage chamber to evacuate and / or fill the storage chamber. Alternatively, the reservoir may include a one-way valve to evacuate the interior of the reservoir and another valve to fill the reservoir storage chamber. In addition, any of numerous different types of bag filling machines and / or methods that are currently known, or will be known later, may be used in turn. Still further, the pump and / or distribution valve can each take a configuration that is different from that described herein. For example, the pump can take the form of any of numerous different pumps that are currently known, or will be known later. For example, the different pumps that are currently known, or that will be known later. For example, the pump may include a piston that is movable within a piston chamber connectable in fluid communication with the variable volume storage tube and / or storage chamber, and a matable portion that is manually engageable to move the piston and, in turn, pump the substance from the variable volume storage chamber through the one-way valve. Alternatively, instead of a dome-shaped member, the pump may define an elastic compression bulb that is manually compressed to distribute a substantially measured volume of fluid from the variable volume storage chamber and through the one-way valve, or can define a different type of manually engageable actuator and a different type of spring, such as spiral spring, or an elastic spring, which creates sufficient spring force in a downward stroke of the manually engageable actuator to return the actuator to its position list when it is released by the user. Alternatively, the pump may include a lever coupled to a piston or a dome-shaped member to distribute fluids through the valve, or may include another type of manually engageable member or pedal that is currently known, or will be known later. Accordingly, this detailed description of currently preferred embodiments will be taken in an illustrative sense, as opposed to a limiting one.

Claims

1. - A flexible bag assembly and valve for aseptically storing a substance, distributing multiple portions of the substance thereof, and keeping the substance remaining in the bag in an aseptic condition sealed from the ambient atmosphere, wherein the flexible bag assembly and valve is received within a relatively rigid housing and is adapted to cooperate with a pump for pumping separate portions of substance from the bag and through the valve of one direction to distribute the substance thereof, the assembly comprising: a flexible bag which defines therein a storage chamber of variable volume sealed with respect to the ambient atmosphere for aseptically storing multiple portions of the substance therein; and a one-way valve including a valve body defining an axially extending valve seat and at least one flow opening extending through at least one valve body and valve seat; and a valve cover mounted on the valve body, and including an axially extending portion formed of an elastic material, which covers the valve seat and covers a substantially axially extending portion thereof, wherein the valve portion defines a predetermined radial thickness and forms an interference fit with the valve seat, the valve portion and the valve seat define a joint that extends axially therebetween to form a normally closed, axially extending valve opening. , and the valve portion is movable radially between (i) a normally closed position with the valve portion engaging the valve seat, and (ii) an open position with at least one segment of the valve portion spaced radially away from the seat valve to connect the valve opening in fluid communication with at least one flow opening and thereby allow the passage e) of the storage chamber substance of variable volume through the valve opening, wherein in the normally closed and open positions the one-way valve maintains the substance remaining in the storage chamber of variable volume in an aseptic condition and sealed with respect to the ambient atmosphere.

2. An assembly according to claim 1, wherein the flexible bag defines a sealed, empty, aseptic storage chamber adapted to receive therein a substance to be stored and distributed therefrom.

3. An assembly according to claim 1, wherein the flexible bag is filled aseptically with a substance that is at least one of a food and beverage.

4. An assembly according to claim 3, wherein the substance is selected from the group that includes a product based on milk, milk, evaporated milk, condensed milk, cream, half and half, formula for babies, milk for growth , yogurt, soup, ice cream, juice, syrup, coffee, condiments, ketchup, mustard, mayonnaise, and coffee aroma.

5. - An assembly according to claim 1, further comprising a flexible tube coupled in fluid communication between the bag and a valve of one direction.

6. - An assembly according to claim 5, wherein the flexible tube is connected to the flexible bag and the valve of one direction by at least one of (i) a fitting mounted to at least one of the flexible bag and a one way valve frictionally engaging a respective end of the tube to form an airtight seal between them, (ii) a heat seal, (iii) a weld, and (iv) an adhesive.

7. - An assembly according to claim 1, wherein the bag is formed of a plastic laminate that includes an oxygen / water barrier and an approved food contact layer.

8. - An assembly according to claim 1, in combination with a distributor comprising a relatively rigid container that receives in it the flexible bag, and a surface to support and place the valve of one direction to distribute substances of the same and to another container.

9. - An assembly and distributor according to claim 8, wherein the distributor further includes a pump operatively coupled between the variable volume storage chamber and the one-way valve, and a control unit electrically coupled to the pump for control the operation of the pump and, in turn, control the distribution of substance within the storage chamber of variable volume, through the valve of one direction, and the other container.

10. An assembly and distributor according to claim 9, wherein the dispenser includes at least one bag, and at least one bag includes at least one of coffee, coffee concentrate, milk, milk-based product, half and half, and cream.

11. An assembly and distributor according to claim 10, wherein the dispenser includes at least one bag containing coffee flavor.

12. - An assembly according to claim 1, further including an elastic actuator coupled in fluid communication between the bag and valve of a direction and manually mobile to pump the substance of the storage chamber of variable volume through the One-way valve

13. - An assembly according to claim 12, wherein the elastic actuator is approximately dome-shaped.

14. An assembly according to claim 13, further comprising a manually engageable operator that is manually engaged to press the elastic actuator and, in turn, distribute the substance of the variable volume storage chamber through the valve of an address.

15. An assembly according to claim 14, wherein the manually engageable operator is a lever.

16. An assembly according to claim 14, further comprising a relatively rigid container that receives in it the flexible bag.

17. An assembly according to claim 16, wherein the relatively rigid container is made of cardboard or plastic.

18. A flexible bag and valve assembly for aseptically storing a substance, distributing multiple portions of the stored substance thereof, and keeping the substance remaining in the bag in an aseptic condition sealed from the ambient atmosphere, wherein the flexible bag and the valve assembly can be received within a relatively rigid housing and adapted to cooperate with a pump for pumping separate portions of substance from the bag and through the valve of one direction to distribute the substance thereof, the assembly comprising: first means that define in them a flexible storage chamber, of variable volume sealed with respect to the ambient atmosphere to store aseptically in it portions of the substance; and second means for allowing the variable volume storage chamber substance to be distributed therethrough, and for keeping the substance remaining in the variable volume storage chamber in an aseptic and sealed condition with respect to the ambient atmosphere during and after distributing the substance through it; wherein the second means includes third means for forming an axially extending valve seat and at least one flow opening, and fourth means mounted on the third means, and including an axially extending, elastic portion covering the third means and covering a substantially axially extending portion thereof, defining a predetermined radial thickness and forming an interference fit with the third means, and defining a joint extending axially between the third and fourth means, to form a valve opening normally closed, extending axially, and to move radially between (i) a normally closed position with the fourth means engaging the third means, and (ii) an open position with at least one segment of the fourth half spaced radially away from the third means for connecting the valve opening in fluid communication with at least one flow opening and thereby allowing the passage of substance from the storage chamber of variable volume through the valve opening, and to maintain the substance remaining in the storage chamber of variable volume in an aseptic condition and sealed with respect to the environmental atmosphere in normally closed and open positions.

19. An assembly according to claim 18, wherein the storage chamber of variable volume contains a milk-based product, and the second means is to substantially prevent microorganisms from entering the storage chamber of variable volume and to allow the milk-based product to be stored and distributed without refrigeration.

20. An assembly according to claim 18, wherein the first means is a flexible bag, and the second means is a valve of one direction, the third means is a valve body, and the fourth means is a cover of flexible valve.

21. A method for storing fluid and distributing multiple portions of the fluid stored therein, comprising the following steps. (1) provide a storage chamber and store therein multiple portions of the fluid in an aseptic condition; (2) providing a one-way valve assembly that includes (i) a valve body defining a valve seat and a flow opening that extends through at least one of the valve body and valve seat; and (ii) a valve cover formed of an elastic material and including a valve portion covering the valve seat, wherein the valve portion defines a predetermined radial thickness and forms an interference fit with the valve seat, the valve portion and the valve seat define a normally closed valve opening, which extends axially therebetween, and the valve portion is movable relative to the valve seat between a normally closed position with the valve portion that engages to the valve seat, and an open position with at least one segment of the valve portion spaced away from the valve seat to connect the valve opening in fluid communication with the flow opening and thereby allow the passage of fluid from the valve seat. the flow opening through the valve opening; and (3) maintaining the fluid in the storage chamber in an aseptic condition during shelf life and distributing the fluid through the one-way valve assembly.

22. A method according to claim 21, further comprising the step of providing a hermetically sealed variable volume storage chamber and storing multiple portions of the fluid in a substantially airless condition therein., and keep the fluid in the variable volume storage chamber substantially airless during shelf life and distribute the fluid through the one-way valve assembly.

23. - A method according to claim 21, further comprising the step of aseptically filling the storage chamber with at least one milk-based product, a baby formula, and a water-based product.

24. - A method according to claim 23, further comprising the step of keeping the milk-based product, infant formula, or water-based product substantially free of preservatives substantially through the filling and distribution of the product.

25. A method according to claim 23, further comprising the step of keeping the milk-based product, baby formula, or water-based product substantially at room temperature through shelf life and distributing multiple product services of the storage chamber. SUMMARY A flexible valve and bag assembly is provided for aseptically storing a substance, dispensing multiple portions of the stored substance therefrom, and keeping the remaining substance in the bag in an aseptic condition sealed from the ambient atmosphere. The bag and flexible valve assembly can be received within a relatively rigid housing, and is adapted to cooperate with a pump for pumping discrete portions of substance from the bag and through the valve of one direction to supply the substance therefrom. The assembly comprises a flexible bag defining there a storage chamber of variable volume sealed with respect to the ambient atmosphere to aseptically store therein multiple portions of the substance. A valve of one direction of the assembly includes a valve body defining a valve seat axially in extension and at least one flow opening extending through the valve body and / or the valve seat. A valve cover is mounted on the valve body, and includes an axially extending portion formed of an elastic material covering the valve seat and covering its portion substantially and axially in extension. The valve portion defines a predetermined radial thickness and forms an interference fit with the valve seat. The valve portion and the valve seat define a seam axially in extension therebetween to form a valve opening axially in extension, normally closed, and the valve portion can be moved radially between (i) a normally closed position with the portion of valve coupling the valve seat, and (ii) an open position with at least one segment of the valve portion spaced radially away from the valve seat to connect the valve opening in fluid communication with at least one flow opening and thus allow the passage of the substance from the variable volume storage chamber through the valve opening. In normally closed and open positions, the one-way valve maintains the remaining substance in the storage chamber of variable volume in an aseptic condition and sealed with respect to the ambient atmosphere.